Delegated Regulation EU/357/2014 of 3 February 2014  was published in the official journal on the 10 April 2014 and will become effective on the 30 April 2014Europe-map-colour
Delegated Regulation EU/357/2014 of 3 February 2014 Supplementing Directive 2001/83/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council as Regards Situations in Which Post-Authorisation Efficacy Studies May be Required. Commission Delegated Regulation (EU) was published in the official journal on the 10 April 2014 and will become effective on the 30 April 2014
The new pharmacovigilance legislation refers to the possibility of requesting a marketing authorisation holder to conduct post-authorisation efficacy studies (PAESs), complementing efficacy data available at the time of the initial authorisation5. To determine situations in which such studies may be required, the Commission is authorised to adopt, by means of a delegated act, measures supplementing the provisions of Directive 2001/83/EC and Regulation (EC) No 726/2004.
Post-authorisation efficacy studies are not a new feature in the EU’s regulatory framework for medicinal products for human use. They have been required for quite some time, especially in the context of conditional marketing authorisations and marketing authorisations under exceptional circumstances7. Likewise, Regulation (EC) No 1901/2006 on paediatric medicines and Regulation (EC) No 1394/2007 on advanced therapy medicinal products9 refer to the possibility of making the performance of specific post-marketing studies a condition of the marketing authorisation.
The added value that the 2010 pharmacovigilance legislation brings is a more global and systematic approach to post-authorisation efficacy studies. Instead of referring to post-marketing studies in different pieces of legislation or hinting at their existence in several provisions, the new rules bring the instrument to the forefront, listing it together with other conditions that may apply to a marketing authorisation.
According to the legal provisions the Commission enjoys discretionary powers in deciding whether to adopt a delegated act. That said, Directive 2001/83/EC and Regulation (EC) No 726/2004 require that any post-authorisation efficacy study imposed as an obligation on the marketing authorisation holder ‘shall be based on the delegated act’. This implies that a delegated act is a pre-condition for imposing post-authorisation efficacy studies. For the application of the new concept, it therefore seems necessary to adopt a delegated act.
Moreover, the delegated act will contribute to predictability and transparency regarding situations in which post-authorisation studies may be required.
The delegated act will be complemented by scientific guidance on post-authorisation efficacy studies that will be drawn up by the European Medicines Agency in accordance with Article 108a of Directive 2001/83/EC.
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